MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ENSEAL; ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

Model Number	ETRIO335H
Health Effect - Clinical Code	Abscess (1690)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During an exploratory laparoscopy, resection of sigmoid colon, drainage of pelvic abscess, colostomy, the enseal device malfunctioned.The upper jaw would not close.It had been working then it stopped.The upper jaw wouldn't come down.It stayed in the up position and could only close with force once removed from the trocar.A new device was obtained and functioned properly.The device was not saved.No harm came to the patient.

• Brand Name: ENSEAL
• Common Device Name: ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 4545 creek rd.; ml #132; cincinnati OH 45242
• MDR Report Key: 9192543
• Report Number: 9192543
• Device Sequence Number: 17058857
• Product Code: GEI
• UDI-Device Identifier: 10705036000297
• UDI-Public: (01)10705036000297
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/02/2019
• Report Date (Section F): 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ETRIO335H
• Device Catalogue Number: ETRIO335H
• Device Lot Number: T93K2L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 82
• Date Report Sent to FDA: 10/02/2019